What are the Rome IV criteria for functional dyspepsia and its treatment options?

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Rome IV Criteria for Functional Dyspepsia

The Rome IV criteria for functional dyspepsia require the presence of one or more bothersome symptoms (epigastric pain, epigastric burning, postprandial fullness, or early satiation) with symptom onset at least 6 months prior to diagnosis, symptoms active within the past 3 months, and no evidence of structural disease likely to explain the symptoms. 1

Diagnostic Criteria for Functional Dyspepsia

  • Functional dyspepsia requires one or more of the following bothersome symptoms:

    • Bothersome epigastric pain
    • Bothersome epigastric burning
    • Bothersome postprandial fullness
    • Bothersome early satiation 1
  • Temporal criteria:

    • Symptom onset at least 6 months prior to diagnosis
    • Symptoms should be active within the past 3 months 1
  • Exclusion criteria:

    • No evidence of structural disease (including at upper endoscopy) likely to explain the symptoms 1

Functional Dyspepsia Subtypes

Functional dyspepsia is divided into two main subtypes:

1. Epigastric Pain Syndrome (EPS)

  • Must include one or both of the following symptoms at least 1 day a week:

    • Bothersome epigastric pain (severe enough to impact usual activities)
    • Bothersome epigastric burning (severe enough to impact usual activities) 1
  • Supportive criteria for EPS:

    • Pain may be induced by ingestion of a meal, relieved by ingestion of meal, or may occur while fasting
    • Postprandial epigastric bloating, belching, and nausea can also be present
    • Persistent vomiting likely suggests another disorder
    • Heartburn is not a dyspeptic symptom but may coexist
    • The pain does not fulfill biliary pain criteria
    • Symptoms relieved by evacuation of feces or gas generally should not be considered part of dyspepsia
    • Other digestive symptoms (such as GERD and IBS) may coexist with EPS 1

2. Postprandial Distress Syndrome (PDS)

  • Must include one or both of the following symptoms at least 3 days a week:

    • Bothersome postprandial fullness (severe enough to impact usual activities)
    • Bothersome early satiation (severe enough to prevent finishing a regular-sized meal) 1
  • Supportive criteria for PDS:

    • Postprandial epigastric pain or burning, epigastric bloating, excessive belching, and nausea can also be present
    • Vomiting warrants consideration of another disorder
    • Heartburn is not a dyspeptic symptom but may coexist
    • Symptoms relieved by evacuation of feces or gas should generally not be considered part of dyspepsia
    • Other digestive symptoms (such as GERD and IBS) may coexist with PDS 1

Clinical Considerations and Pitfalls

  • The Rome IV criteria are more restrictive than previous iterations, resulting in a lower prevalence of functional dyspepsia (approximately 7% globally compared to nearly 30% with broader definitions) 1, 2

  • The Rome Foundation has developed less restrictive "clinical criteria" for use in routine clinical practice that only require symptoms to be present for 8 weeks rather than the 6-month onset required by Rome IV 1

  • Overlap between EPS and PDS occurs in approximately 21-35% of patients with functional dyspepsia under Rome IV criteria, which is reduced compared to the 67% overlap seen with Rome III criteria 3

  • Functional dyspepsia and gastroparesis have significant overlapping features and cannot be fully distinguished based on symptoms or gastric emptying studies alone; the term "FD with or without delayed gastric emptying" may be preferable 1

  • Approximately 80% of people with dyspepsia in community surveys have functional dyspepsia, with the remainder having organic causes such as erosive esophagitis (13%), peptic ulcer (8%), or gastroesophageal cancer (<0.5%) 1

  • Risk factors for functional dyspepsia include younger age, female sex, higher levels of somatoform-type symptom reporting, and other digestive disorders including IBS 1, 2

  • Patients with overlapping EPS and PDS subtypes typically show greater somatization and poorer quality-of-life scores than those with either subtype alone 2

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Effects of Rome IV Definitions of Functional Dyspepsia Subgroups in Secondary Care.

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2021

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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